Samil Pharmaceutical announced on the 25th that it has released ‘Amelibuju (ingredient: ranibizumab)’, a biosimilar of ‘Lucentis’, which has signed a domestic distribution and sales contract with Samsung Bioepis.
Amelibu is a biosimilar product of ‘Lucentis’ developed by Samsung Bioepis. It binds to vascular endothelial factor (VEGF)-A and inhibits the formation of new blood vessels. It is an eye disease treatment that has efficacy in the treatment of visual impairment caused by sexual and diabetic macular edema.
From March 2018 to December 2019, Samsung Bioepis conducted a phase 3 clinical trial of Amelivuzu on 705 patients with neovascular age-related macular degeneration (nAMD) in 9 countries.
As the primary endpoint, changes in best corrected visual acuity (BCVA) and central subfield thickness (CST) were measured for 8 weeks following drug prescription, and both were measured. The pre-established equivalence range was met.
In addition, Samsung Bioepis has confirmed the efficacy, safety, and immunogenicity of the original drug and Amelibu Inj (project name: SB11) through the results of phase 3 clinical trials announced at the summer academic conference of the Korean Retina Society in June last year.
Heo Seung-beom, CEO of Samil Pharmaceutical, said, “Samil Pharmaceutical is pursuing the realization of total care in the field of ophthalmology through the introduction of products from global partners in addition to various self-developed products.” We have established a lineup of all products necessary for treatment,” he said.
Samsung Bioepis Vice President Park Sang-jin (Head of Commercial Headquarters) said, “By launching Amelivu, we can provide more treatment opportunities using high-quality medicines to domestic ophthalmological patients.” We will continue to strive to improve patient convenience.”
Meanwhile, Amelibuzu is the sixth biosimilar product developed and commercialized by Samsung Bioepis and the first eye disease treatment. did.
